Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients

NCT06161181 | Completed

• 1 other identifier: IEO1907
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Emerging evidence indicates that patients with advanced cancer, such as those with MBC, often exhibit significant levels of nonadherence to oral anticancer treatments. Leveraging of the machine learning models in clinical practice enables the provision of personalized predictions on medication adherence for individual patients, thereby supporting adherence and facilitating targeted interventions. Objective: The current protocol aims to assess the efficacy of the DSS, a web-based solution named TREAT (TREatment Adherence SupporT), and a machine learning web application in promoting adherence to oral anticancer treatments within a sample of MBC patients. Methods and Design: This protocol is part of a project titled "Enhancing Therapy Adherence Among Metastatic Breast Cancer Patients" (Tracking Number 65080791). A sample of 100 MBC patients is enrolled consecutively and admitted to the Division of Medical Senology of the European Institute of Oncology. 50 MBC patients receive the DSS for three months (experimental group), while 50 MBC patients not subjected to the intervention receive standard medical advice (control group). The protocol foresees three assessment time points: T1 (1-Month), T2 (2-Month), and T3 (3-Month). At each time point, participants fill out a set of self-reports evaluating adherence, clinical, psychological, and QoL variables. Conclusions: our results will inform about the effectiveness of the DSS and risk-predictive models in fostering adherence to oral anticancer treatments in MBC patients.

Conditions

Metastatic Breast Cancer

Keywords

adherence; oral anticancer treatment; risk predictive model; decision support system

Outcome Measures

Primary Outcomes (1)

• Decision Support System Effectiveness

  Evaluating the effectiveness of the DSS web-based solution and machine learning web application (TREAT - "TREatment Adherence SupporT") in fostering adherence to oral anticancer treatments

  3 Months

Secondary Outcomes (2)

• Clinical, Psychological and Quality of Life Predictors of Adherence

  3 Months

• Psychological Predictors of Adherence

  3 Months

Study Arms (2)

Experimental Group

EXPERIMENTAL

50 MBC patients receive the DSS for three months. Patients are instructed to use the DSS ad libitum.

Device: Decision Support System

Control Group

NO INTERVENTION

50 MBC patients not subjected to the intervention receive standard medical advice.

Interventions

Decision Support System DEVICE

TREAT (TREatment Adherence SupporT) is a web-based DSS that comprises four sections: i) Metastatic Breast Cancer: contains information about MBC and its physical and psychological consequences; ii) Adherence to Cancer Therapies: contains information about adherence in the cancer population; iii) Promoting Adherence: contains information about resources, barriers, and available interventions used to foster adherence; iv) My Adherence Diary.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years-old;
• Having a metastatic breast cancer diagnosis;
• Taking oral treatment intervention for metastatic breast cancer;
• Patients with internet access and a personal smartphone or tablet;
• Patients who have read and signed the informed consent.

You may not qualify if:

• Presence of primary psychiatric or neurological conditions;
• Patients who refused to sign the informed consent.

Sponsors & Collaborators

• Pfizer: collaborator
• European Institute of Oncology: lead

Study Sites (1)

European Institute fo Oncology

Milan, MI, 20141, Italy

Location

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gabriella pravettoni, PhD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: May 3, 2023
• Primary Completion: February 15, 2024
• Study Completion: May 15, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IT (1)